Adjusted research and development (R&D) expenses were $164 million, down 13% year over year.

Adjusted selling, general and administrative (SG&A) expenses were $278 million, up 13.4% year over year.

Full Year 2018 Results

The company reported adjusted earnings of $7.92, up 35% year over year. The company’s revenues were $4.131 billion, up 16% year over year.

2019 Guidance

The company expects earnings per share to be $9.10-$9.30. Alexion projects revenues of $4.63-$4.70 billion in 2019. The Zacks Consensus Estimate for earnings in 2019 is pegged at $8.78, while for sales it is $4.76 billion.

Revenues for Soliris and Ultomiris are expected in the $3.97-$4.02 billion range.

Pipeline Update

In January 2019, Alexion announced positive top-line results from a phase III study of Ultomiris in complement inhibitor naïve patients with aHUS. The study met its primary objective with 53.6% of patients demonstrating complete thrombotic microangiopathy (TMA) response.

In December 2018, the FDA approved Ultomiris for adults with PNH. Applications for approval in the European Union (EU) and Japan are currently under review. A phase III study of Ultomiris in children and adolescents with PNH is currently underway.

Alexion has submitted applications in the United States and the EU for the approval of Soliris for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).

A phase I study of subcutaneous ALXN1210 co-administered with Halozyme Therapeutics, Inc.’s HALO ENHANZE drug-delivery technology, PH20 is underway. Pending co-formulation data, this next-generation subcutaneous formulation will be called ALXN1810, and has the potential to further extend the dosing interval to once every two weeks or once per month.

Duringthe fourth quarter of 2018, Alexion acquired Syntimmune. The acquisition added anti-FcRn antibody ALXN1830 (SYNT001) to the company's clinical pipeline. ALXN1830 is currently in phase Ib/IIa development in patients with warm autoimmune hemolytic anemia (WAIHA) and those with pemphigus vulgaris (PV) or pemphigus foliaceus (PF).

Our Take

Alexion topped earnings and sales estimates in the fourth quarter of 2018. We expect Soliris to continue driving the company’s growth. In the meantime, other new products — Strensiq and Kanuma — are doing well and likely to boost revenues. The company also launched Ultomiris in the United States for the treatment of PNH.

We are also impressed with Alexion’s efforts to develop its pipeline. Its application for Ultomiris is under review in the EU and Japan for the treatment of PNH. The company completed the acquisition of Syntimmune to further diversify its rare diseases pipeline.

Companies like Achillion Pharmaceuticals Inc. ACHN and Akari Therapeutics, Plc AKTX are also developing drugs for the treatment of PNH.

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